[ Superseding IS 12572 (Part 13) : 1995 /ISO 10993-3 : 1992 ]

Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 3) (First Revision) which is identical with ISO 10993-3 : 2014 ‘Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity’ issued by the International Organization for Standardization (ISO) was adopted by Bureau of Indian Standards on recommendation of the Biological and Clinical Evaluation of Medical Devices and Immuno-Biological Diagnostic Kits Sectional Committee, and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was originally published in 1995 and was identical with ISO 10993-3 : 1992. The first revision of this standard has been undertaken to align it with the latest version of ISO 10993-3 : 2014.

The text of ISO standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker, while in Indian Standards, the current practice is to use a point (.) as the decimal marker.